Recalls / Class II
Class IID-0177-2016
Product
PGE 30mcg/ml Injection, 10 mL vials, Rx, B & B Health Mart Pharmacy, Bellflower, CA
- Affected lot / code info
- 07062015@8, exp 1/2/2016; 07162015@7, exp 1/12/2016; 07272015@5, exp 1/23/2016; 08142015@9, exp 2/10/2016
Why it was recalled
Lack of Assurance of Sterility; FDA inspection identified GMP violations potentially impacting product quality and sterility
Recalling firm
- Firm
- Pacific Healthcare, Inc dba B&B Pharmacy
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 10244 Rosecrans Ave, N/A, Bellflower, California 90706-2602
Distribution
- Quantity
- 4 vials
- Distribution pattern
- CA and NJ
Timeline
- Recall initiated
- 2015-10-07
- FDA classified
- 2015-11-10
- Posted by FDA
- 2015-11-18
- Terminated
- 2016-04-07
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0177-2016. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.